CN104739764A - Fat emulsion injection and preparation method thereof - Google Patents
Fat emulsion injection and preparation method thereof Download PDFInfo
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- CN104739764A CN104739764A CN201310754335.8A CN201310754335A CN104739764A CN 104739764 A CN104739764 A CN 104739764A CN 201310754335 A CN201310754335 A CN 201310754335A CN 104739764 A CN104739764 A CN 104739764A
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Abstract
The invention provides a fat emulsion injection. The fat emulsion injection is prepared from an oil phase, an aqueous phase, a stabilizer and a pH regulator, wherein the oil phase contains one or more of soybean oil, medium chain triglyceride, olive oil and fish oil; in the fat emulsion injection, emulsion particles with particle size more than or equal to 0.1 micron account for more than 80% and emulsion particles with particle size more than or equal to 1.0 micron account for 0%. The invention also provides a method for preparing the fat emulsion injection. The invention can better relieve the problem of relatively narrow emulsion particle distribution, enhance the uniformity of the emulsion particles and improve the stability of the fat emulsion injection; and the adverse reaction of the emulsion agent is reduced and administration safety is enhanced.
Description
Technical field
The present invention relates to a kind of fat emulsion injection and preparation method thereof.
Background technology
Fat emulsion injection develops into the third generation so far, first on behalf of fat emulsion injection (C14-24), during the second filial generation mainly contains/and long chain fat emulsion injection (C6-24), fish oil fat emulsion injection and long chain fat emulsion injection (OO), latest generation fat milk to mainly contain in structural fatty emulsion injection, multiple oil and fat emulsion injection and fish oil/long chain fat emulsion injection.All enuatrol is with the addition of in fat emulsion injection by the second filial generation.The effect of enuatrol main stabilization agent in Emulsion, enhances emulsifying capacity.
The preparation key technology of Emulsion: utilize a kind of oil or several oil mixing to make stable, mean diameter at 200 ~ 500 nanometers, size lactoconium generally between 100 ~ 1000 nanometers after emulsifying homogeneous, focus on how ensureing the homogeneity of newborn grain and the stability of storage period in preparation technology.
Current Emulsion class injection has following two kinds of methods preparation (as number of patent application preparation method disclosed in the patent application of 200610097599.0 and 200810115380.8):
1.. prepared by oil phase: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 90 DEG C, add lecithin, after dispersed with stirring and get final product; Prepared by aqueous phase: get glycerol and enuatrol adds in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 90 DEG C and get final product; Inject water to amount of preparation by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers under a certain pressure, namely homogenizing obtains Emulsion several times.
2.. prepared by oil phase: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 90 DEG C, obtain final product; Prepared by aqueous phase: get glycerol and enuatrol adds in appropriate water for injection, and stirring and dissolving post-heating to 60 ~ 90 DEG C, add lecithin, after dispersed with stirring and get final product; Inject water to amount of preparation by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers under a certain pressure, namely homogenizing obtains Emulsion several times.
Above two kinds of methods are all added by enuatrol in aqueous phase to mix rear homogenizing again with oil phase, and the method obtains the newborn grain wider distribution of Emulsion, and the newborn grain content being less than 0.1um is more, the less stable of such Emulsion.The stability of Emulsion and the size of emulsion droplet have substantial connection, in Emulsion, drop size is inhomogenous, little emulsion droplet is filled between large emulsion droplet usually, the aggregation of emulsion droplet is increased, easily cause the merging of emulsion droplet, so the stability in order to ensure Emulsion, when preparing Emulsion, keep the homogeneity of emulsion droplet as much as possible.The newborn grain distribution of Emulsion is wide, and Emulsion easily occurs after mixing with other injection and is destroyed, newborn grain increases, the various problem such as layering.For better ensureing the stability of Emulsion, the content of less newborn grain and larger newborn grain need be reduced as far as possible.
Summary of the invention
Technical scheme of the present invention there is provided a kind of fat emulsion injection.Another technical scheme of the present invention there is provided the preparation method of this fat emulsion injection.
The invention provides a kind of fat emulsion injection, the raw material of this fat emulsion injection through including oil phase, aqueous phase, stabilizing agent and pH adjusting agent is prepared from, and described oil phase contains one or more in soybean oil, medium chain triglyceride, olive oil and fish oil; In described fat emulsion injection, the newborn grain content of particle diameter >=0.1um is more than 80%, and the newborn grain content of particle diameter >=1.0um is 0%.
Wherein, described stabilizing agent is enuatrol, and described pH adjusting agent is sodium hydroxide.
Wherein, the oil content in described fat emulsion injection is 10 ~ 30%(g/L).
Wherein, the oil content in described fat emulsion injection is 10 ~ 20%(g/L).
Wherein, in described fat emulsion injection, the newborn grain content of particle diameter >=0.1um is 90%, the newborn grain of particle diameter >=1.0um; Oil content in described fat emulsion injection is 20 ~ 30%(g/L), preferred 20%(g/L).
" oil content in fat emulsion injection " of the present invention, refers to that total oil quality (g) accounts for the degree of fat emulsion injection cumulative volume (L), and wherein, total oil quality is the total content of soybean oil in injection, medium chain triglyceride, olive oil, fish oil.
Wherein, described fat emulsion injection it prepared by following method:
A, prepare oil phase and aqueous phase;
B, inject water to amount of preparation by after oil phase and aqueous phase mix and blend, cross high pressure homogenizer;
C, use high pressure homogenizer homogenizing again, obtain homogeneous latex emulsion;
D, fill, jump a queue after filling nitrogen, gland, sterilizing, obtain fat emulsion injection;
Wherein, after b step homogenizing or after step c homogenizing, stabilizing agent is added; When a step prepares aqueous phase, before b step homogenizing or after homogenizing, or add pH adjusting agent after step c homogenizing.
Wherein, described fat emulsion injection is also containing glycerol, lecithin or vitamin E.
Wherein, lecithin is contained in described oil phase or aqueous phase.
Wherein, the sterilizing methods described in steps d is: in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes.
Wherein, described fat emulsion injection be in/long chain fat emulsion injection, long chain fat emulsion injection (OO), in fish oil/long chain fat emulsion injection, fish oil fat emulsion injection or multiple oil and fat emulsion injection, middle long chain fat emulsion/aminoacid/glucose injection, long chain fat emulsion/aminoacid/glucose injection, long chain fat emulsion/aminoacid/glucose injection or multiple oil and fat breast/aminoacid/glucose injection in olive oil fat milk/aminoacid/glucose injection or fish oil.
Present invention also offers a kind of method preparing fat emulsion injection, it comprises the steps:
1) oil phase and aqueous phase is prepared;
2) inject water to amount of preparation by after oil phase and aqueous phase mix and blend, cross high pressure homogenizer;
3) use high pressure homogenizer homogenizing again, obtain homogeneous latex emulsion;
4) fill, jump a queue after filling nitrogen, gland, sterilizing, obtain fat emulsion injection;
Wherein, in step 2) after homogenizing or add stabilizing agent after step 3) homogenizing; When step 1) prepares aqueous phase, in step 2) before homogenizing or after homogenizing, or pH adjusting agent is added after step 3) homogenizing.
Wherein, step 2) described in high pressure homogenizer preferably two step high pressure homogenizers, processing condition is: homogenization pressure is one-step valve 400 ~ 800bar, is preferably 600 ~ 800bar; Secondary valve is 0 ~ 200bar; Homogenization cycles is at 2 ~ 4 times, and homogenizing temperature is 50 ~ 65 DEG C.
Wherein, the high pressure homogenizer described in step 3) is two step high pressure homogenizers preferably, and homogenization pressure is: homogenization pressure is one-step valve 120 ~ 200bar, secondary valve is 0 ~ 200bar, and homogenizing temperature is 50 ~ 65 DEG C.
Wherein, described two step high pressure homogenizers, the one of namely commercially available at present conventional homogenizer, it is with two-stage homogenizing valve, and wherein the first order is high pressure, and the second level is low pressure.
Wherein, the preparation method of oil phase described in step 1) is: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, is heated to 60 ~ 85 DEG C and get final product; The preparation method of described aqueous phase is: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C and get final product.
Wherein, lecithin is contained in described oil phase or aqueous phase.
Wherein, the sterilizing methods described in step 4) is: in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes.
The present invention prepares the method for fat emulsion injection, specifically comprises following several method:
1. oil phase preparation: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 85 DEG C, add lecithin, after dispersed with stirring and get final product; Prepared by aqueous phase: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C and get final product; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 400 ~ 800bar, secondary valve is 0 ~ 200bar, homogenization cycles is at 2 ~ 4 times, homogenizing temperature is 50 ~ 65 DEG C, adds sodium oleate solution and appropriate sodium hydroxide solution, uses two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 120 ~ 200bar, secondary valve is 0 ~ 200bar, obtains homogeneous latex emulsion.By emulsion fill in transfusion bottle/bag, jump a queue after filling nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
2. oil phase preparation: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 85 DEG C, obtain final product; Prepared by aqueous phase: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C, add lecithin, after dispersed with stirring and get final product; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 400 ~ 800bar, secondary valve is 0 ~ 200bar, homogenization cycles is at 2 ~ 4 times, homogenizing temperature is 50 ~ 65 DEG C, add sodium oleate solution and appropriate sodium hydroxide solution, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 120 ~ 200bar, secondary valve is that 0 ~ 200bar obtains homogeneous latex emulsion.By emulsion fill in transfusion bottle/bag, jump a queue after filling nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
3. oil phase preparation: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 85 DEG C, add lecithin, after dispersed with stirring and get final product; Prepared by aqueous phase: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C and get final product; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 400 ~ 800bar, secondary valve is 0 ~ 200bar, homogenization cycles is at 2 ~ 4 times, homogenizing temperature is 50 ~ 65 DEG C, then regulates that homogenization pressure is one-step valve 120 ~ 200bar, secondary valve is 0 ~ 200bar homogenizing 1 time.Add sodium oleate solution and appropriate sodium hydroxide solution, after stirring evenly by emulsion fill in transfusion bottle/bag, jump a queue after filling nitrogen, gland, in rotation sterilizing cabinet in 121 DEG C insulation 12 minutes, to obtain final product.
Present invention also offers the fat emulsion injection be prepared from through the described method preparing fat emulsion injection.
The present invention decreases the problem of newborn grain wider distribution very well, adds the homogeneity of newborn grain, improves the stability of fat emulsion injection; Decrease the untoward reaction of Emulsion, add drug safety.
Accompanying drawing explanation
The first preparation technology's flow chart of Fig. 1 fat emulsion injection of the present invention;
The second preparation technology flow chart of Fig. 2 fat emulsion injection of the present invention;
The third preparation technology's flow chart of Fig. 3 fat emulsion injection of the present invention.
Detailed description of the invention
The preparation of embodiment 1 fat emulsion injection of the present invention
Prepared by oil phase: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 85 DEG C, add lecithin, after dispersed with stirring and get final product; Prepared by aqueous phase: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C and get final product; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers and complete higher pressure homogenizing step, homogenization pressure is one-step valve 400 ~ 800bar, and secondary valve is 0 ~ 200bar, and homogenization cycles is within 4 times, homogenizing temperature is 50 ~ 65 DEG C, add sodium oleate solution and appropriate sodium hydroxide solution, complete comparatively low pressure homogenizing step with two step high pressure homogenizers again after mixing, homogenizing 1 time, homogenization pressure is one-step valve 120 ~ 200bar, and secondary valve is 0 ~ 200bar.(concrete technology program is shown in Fig. 1, omnidistance nitrogen filled protection during preparation)
The preparation of embodiment 2 fat emulsion injection of the present invention
Prepared by oil phase: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 85 DEG C, obtain final product; Prepared by aqueous phase: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C, add lecithin, after dispersed with stirring and get final product; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers and complete higher pressure homogenizing step, homogenization pressure is one-step valve 400 ~ 800bar, and secondary valve is 0 ~ 200bar, and homogenization cycles is within 4 times, homogenizing temperature is 50 ~ 65 DEG C, add sodium oleate solution and appropriate sodium hydroxide solution, complete higher pressure homogenizing step with two step high pressure homogenizers again after mixing, homogenizing 1 time, homogenization pressure is one-step valve 120 ~ 200bar, and secondary valve is 0 ~ 200bar.(concrete technology flow process is shown in Fig. 2, omnidistance nitrogen filled protection during preparation)
The preparation of embodiment 3 fat emulsion injection of the present invention
Prepared by oil phase: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, be heated to 60 ~ 85 DEG C, add lecithin, after dispersed with stirring and get final product; Prepared by aqueous phase: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C and get final product; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 400 ~ 800bar, secondary valve is 0 ~ 200bar, homogenization cycles is at 2 ~ 4 times, homogenizing temperature is 50 ~ 65 DEG C, then regulates that homogenization pressure is one-step valve 120 ~ 200bar, secondary valve is 0 ~ 200bar homogenizing 1 time.Add sodium oleate solution and appropriate sodium hydroxide solution, after stirring evenly by emulsion fill in transfusion bottle/bag, jump a queue after filling nitrogen, gland, in rotation sterilizing cabinet in 121 DEG C insulation 12 minutes, to obtain final product.(concrete technology flow process is shown in Fig. 3, omnidistance nitrogen filled protection during preparation)
In embodiment 4 the present invention/long chain fat emulsion injection
Example 1
Get 100g soybean oil and 100g medium chain triglyceride, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 3 times, homogenizing temperature is 50 ~ 55 DEG C, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, two step high pressure homogenizer homogenizing 1 time is used again after mixing, homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtains homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.This routine oil content is 20%(g/L).
Example 2
Get 100g soybean oil and 100g medium chain triglyceride, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 3 times, homogenizing temperature is 60 ~ 65 DEG C, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, two step high pressure homogenizer homogenizing 1 time is used again after mixing, homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtains homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.This routine oil content is 20%(g/L).
Example 3
Get 100g soybean oil and 100g medium chain triglyceride, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 800bar, secondary valve is 0bar, homogenizing 3 times, homogenizing temperature is 60 ~ 65 DEG C, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.This routine oil content is 20%(g/L).
Example 4
Get 100g soybean oil and 100g medium chain triglyceride, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 2 times, homogenizing temperature is 55 ~ 60 DEG C, and adjustment homogenization pressure is one-step valve 160bar, secondary valve is 120bar homogenizing 1 time, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, make pH be 9.0 ~ 9.5, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.This routine oil content is 20%(g/L).
Example 5
Get 50g soybean oil and 50g medium chain triglyceride, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 400bar, secondary valve is 50bar, homogenizing 2 times, homogenizing temperature is 50 ~ 55 DEG C, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 120bar, secondary valve is 50bar, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.This routine oil content is 10%(g/L).
Reference examples 1
Get 100g soybean oil and 100g medium chain triglyceride, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Get 25g glycerol and 0.3g enuatrol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; After oil phase and aqueous phase mix and blend, add appropriate sodium hydroxide solution, inject water to amount of preparation, prepare the injection that oil content is 20% (g/L), cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 3 times, homogenizing temperature is 50 ~ 55 DEG C, then regulate that homogenization pressure is one-step valve 160bar, secondary valve be 120bar homogenizing once, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Reference examples 2
Get 50g soybean oil and 50g medium chain triglyceride, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Get 25g glycerol and 0.3g enuatrol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; After oil phase and aqueous phase mix and blend, add appropriate sodium hydroxide solution, prepare the injection that oil content is 10% (g/L), inject water to amount of preparation, cross two step high pressure homogenizers, homogenization pressure is one-step valve 500bar, secondary valve is 50bar, homogenizing 1 time, homogenizing temperature is 50 ~ 55 DEG C, then regulate that homogenization pressure is one-step valve 120bar, secondary valve be 50bar homogenizing once, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Stability experiment is studied
According to the regulation about medicine stability test in " chemicals stability techniques research guideline ", study on the stability is carried out to several fat emulsion injection.According to the homogeneity that the object of this research is improvement fat emulsion injection breast grain, thus the stability increased in long-term put procedure, carry out long-term experiment investigation to the newborn grain of several fat emulsion injection and layering (phenomenon that dispersed phase particles floats or sinks appears in Emulsion after placing) situation, concrete outcome is as follows:
Table 1: in/long chain fat emulsion injection
Note: the criterion of layering refers to 180 degree, the container of the slowly inclination splendid attire Emulsion when observing, be minute quantity when needing the color of emulsion and top emulsion bottom extremely examining inconsistent in tilting procedure, slightly examine in tilting procedure the color of bottom emulsion and top emulsion inconsistent time be a small amount of, be obvious time directly inconsistent to the color of emulsion bottom observation and top emulsion in tilting procedure.
In embodiment 5 fish oil of the present invention/long chain fat emulsion injection (oil content 20%(g/L))
Example 1
Get 80g soybean oil, 100g medium chain triglyceride, 0.2g vitamin E and 20g fish oil, be heated to 60 ~ 70 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 70 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 700bar, secondary valve is 80bar, homogenizing 2 times, homogenizing temperature is 50 ~ 55 DEG C, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 120bar, secondary valve is 80bar, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.The high pressure homogenizer that this example uses is two step high pressure homogenizers, and model is apv1000, can certainly select two step high pressure homogenizers of other model, also can select only containing the high pressure homogenizer of one-step valve.
Example 2
Get 80g soybean oil, 100g medium chain triglyceride, 0.2g vitamin E and 20g fish oil, be heated to 60 ~ 70 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 70 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 150bar, homogenizing 2 times, homogenizing temperature is 60 ~ 65 DEG C, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 150bar, secondary valve is 0bar, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 3
Get 80g soybean oil, 100g medium chain triglyceride, 0.2g vitamin E and 20g fish oil, be heated to 60 ~ 70 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 70 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 800bar, secondary valve is 0bar, homogenizing 2 times, homogenizing temperature is 60 ~ 65 DEG C, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 160bar, secondary valve is 0bar, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 4
Get 80g soybean oil, 100g medium chain triglyceride, 0.2g vitamin E and 20g fish oil, be heated to 60 ~ 70 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 70 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 700bar, secondary valve is 80bar, homogenizing 2 times, homogenizing temperature is 50 ~ 55 DEG C, then homogenization pressure be one-step valve 120bar, secondary valve is 80bar, obtain homogeneous latex emulsion, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, make pH be 9.0 ~ 9.5, stir evenly.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Reference examples
Get 80g soybean oil, 100g medium chain triglyceride, 0.2g vitamin E and 20g fish oil, be heated to 60 ~ 70 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Get 25g glycerol and 0.3g enuatrol adds in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 70 DEG C, obtained aqueous phase; After oil phase and aqueous phase mix and blend, add appropriate sodium hydroxide solution, inject water to amount of preparation, prepare the injection that oil content is 20% (g/L), cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 2 times, homogenizing temperature is 50 ~ 55 DEG C, then regulate that homogenization pressure is one-step valve 160bar, secondary valve be 120bar homogenizing once, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Table 2: in fish oil/long chain fat emulsion injection study on the stability
Embodiment 6 long chain fat emulsion injection of the present invention (OO) (oil content 20% (g/L))
Example 1
Get 40g soybean oil and 160g olive oil, be heated to 75 ~ 85 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 22.5g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 700bar, secondary valve is 120bar, homogenizing 4 times, homogenizing temperature is 50 ~ 55 DEG C, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, two step high pressure homogenizer homogenizing 1 time is used again after mixing, homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtains homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 2
Get 40g soybean oil and 160g olive oil, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 22.5g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 150bar, homogenizing 4 times, homogenizing temperature is 60 ~ 65 DEG C, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, two step high pressure homogenizer homogenizing 1 time is used again after mixing, homogenization pressure is one-step valve 180bar, secondary valve is 150bar, obtains homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 3
Get 40g soybean oil and 160g olive oil, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 22.5g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 800bar, secondary valve is 80bar, homogenizing 4 times, homogenizing temperature is 60 ~ 65 DEG C, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 160bar, secondary valve is 80bar, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 4
Get 40g soybean oil and 160g olive oil, be heated to 75 ~ 85 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 22.5g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 700bar, secondary valve is 120bar, homogenizing 4 times, homogenizing temperature is 50 ~ 55 DEG C, then regulates that homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtain homogeneous latex emulsion, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, make pH be 9.0 ~ 9.5, stir evenly.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Reference examples
Get 40g soybean oil and 160g olive oil, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Get 22.5g glycerol and 0.3g enuatrol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; After oil phase and aqueous phase mix and blend, add appropriate sodium hydroxide solution, inject water to amount of preparation, prepare the injection that oil content is 20% (g/L), cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 5 times, homogenizing temperature is 50 ~ 55 DEG C, then regulate that homogenization pressure is one-step valve 160bar, secondary valve be 120bar homogenizing once, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Table 3: long chain fat emulsion injection (OO) stability test is investigated
The multiple oil and fat emulsion injection of embodiment 7 the present invention (oil content 20% (g/L))
Example 1
Get 60g soybean oil, 60g medium chain triglyceride, 50g olive oil, 30g fish oil and vitamin E, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 3 times, homogenizing temperature is 50 ~ 55 DEG C, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, two step high pressure homogenizer homogenizing 1 time is used again after mixing, homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtains homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 2
Get 60g soybean oil, 60g medium chain triglyceride, 50g olive oil, 30g fish oil and vitamin E, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 3 times, homogenizing temperature is 60 ~ 65 DEG C, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, two step high pressure homogenizer homogenizing 1 time is used again after mixing, homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtains homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 3
Get 60g soybean oil, 60g medium chain triglyceride, 50g olive oil, 30g fish oil and vitamin E, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 800bar, secondary valve is 0bar, homogenizing 3 times, homogenizing temperature is 60 ~ 65 DEG C, adds sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, pH is made to be 9.0 ~ 9.5, use two step high pressure homogenizer homogenizing 1 time after mixing again, homogenization pressure is one-step valve 160bar, secondary valve is 120bar, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Example 4
Get 60g soybean oil, 60g medium chain triglyceride, 50g olive oil, 30g fish oil and vitamin E, be heated to 70 ~ 80 DEG C, add 12g lecithin, dispersed with stirring, obtained oil phase; Getting 25g glycerol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; Amount of preparation is injected water to by after oil phase and aqueous phase mix and blend, cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 3 times, homogenizing temperature is 50 ~ 55 DEG C, regulate homogenization pressure be one-step valve 160bar, secondary valve be 120bar homogenizing once, obtain homogeneous latex emulsion, add sodium oleate solution (0.3g enuatrol dissolves with a small amount of water for injection and get final product) and appropriate sodium hydroxide solution, make pH be 9.0 ~ 9.5, stir evenly.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Reference examples
Get 60g soybean oil, 60g medium chain triglyceride, 50g olive oil, 30g fish oil and vitamin E, add 12g lecithin, dispersed with stirring, obtained oil phase; Get 25g glycerol and 0.3g enuatrol adds in appropriate water for injection, stirring and dissolving post-heating to 70 ~ 80 DEG C, obtained aqueous phase; After oil phase and aqueous phase mix and blend, add appropriate sodium hydroxide solution, inject water to amount of preparation, prepare the injection that oil content is 20% (g/L), cross two step high pressure homogenizers, homogenization pressure is one-step valve 600bar, secondary valve is 120bar, homogenizing 3 times, homogenizing temperature is 50 ~ 55 DEG C, then regulate that homogenization pressure is one-step valve 160bar, secondary valve be 120bar homogenizing once, obtain homogeneous latex emulsion.By emulsion fill in infusion bottle, jump a queue after inflated with nitrogen, gland, in rotation sterilizing cabinet, 121 DEG C are incubated 12 minutes, to obtain final product.
Table 4: multiple oil and fat emulsion injection
In sum, the stability of the fat emulsion injection produced after regulating preparation technology improves significantly.
Brief summary and analysis:
In fat emulsion injection prepared by the present invention, the ratio of breast grain particle diameter >=0.1um is larger, illustrate that the content of little newborn grain is fewer, the ratio of particle diameter >=1.0um is less, then illustrate that the content of large newborn grain is fewer, and control >=0.1um and the >=newborn grain content of 1.0um, make newborn grain between 0.1um and 1.0um, the homogeneity of newborn grain can be increased. simultaneously
Concordance numerical value is less, and the distribution of newborn grain is narrower, and namely homogeneity is better, and Emulsion is more stable.
By known in embodiment 4-7:
In reference examples, conventionally first stabilizing agent is prepared aqueous phase, then prepare emulsion with oil phase; In example of the present invention, first by after aqueous phase and the process of oil phase homogenizing, then add stabilizing agent homogenizing or mixing, preparation emulsion.
The emulsion of same oil content compared, in the inventive method products obtained therefrom, the ratio of particle diameter >=0.1um is apparently higher than reference examples product, and does not have the newborn grain of particle diameter >=1.0um, and homogeneity is obviously better than reference examples product; In stability test, the inventive method products obtained therefrom occurs that the resting period of layering is obviously longer than reference examples product.
Be not difficult to find out from the above results contrast, the present invention adopts specific stabilizing agent feed postition, significantly improves the homogeneity of emulsion finished product, also significantly enhances product stability simultaneously.
Claims (10)
1. a fat emulsion injection, is characterized in that, the raw material of this fat emulsion injection through including oil phase, aqueous phase, stabilizing agent and pH adjusting agent is prepared from, and described oil phase contains one or more in soybean oil, medium chain triglyceride, olive oil and fish oil; In described fat emulsion injection, the newborn grain content of particle diameter >=0.1um is more than 80%, and the newborn grain content of particle diameter >=1.0um is 0%.
2. fat emulsion injection according to claim 1, is characterized in that, described stabilizing agent is enuatrol, and described pH adjusting agent is sodium hydroxide; Oil content in described fat emulsion injection is 10 ~ 30%(g/L).
3. fat emulsion injection according to claim 1, is characterized in that, in described fat emulsion injection, the newborn grain content of particle diameter >=0.1um is 90%, the newborn grain of particle diameter >=1.0um; Oil content in described fat emulsion injection is 20% ~ 30%(g/L), preferred 20%(g/L).
4., according to the arbitrary described fat emulsion injection of claim 1-3, it is characterized in that, it is prepared by following method:
A, prepare oil phase and aqueous phase;
B, inject water to amount of preparation by after oil phase and aqueous phase mix and blend, cross high pressure homogenizer;
C, use high pressure homogenizer homogenizing again, obtain homogeneous latex emulsion;
D, fill, jump a queue after filling nitrogen, gland, sterilizing, obtain fat emulsion injection;
Wherein, after b step homogenizing or after step c homogenizing, stabilizing agent is added; When a step prepares aqueous phase, before b step homogenizing or after homogenizing, or add pH adjusting agent after step c homogenizing.
5. fat emulsion injection according to claim 1, is characterized in that: described fat emulsion injection is also containing glycerol, lecithin or vitamin E.
6. fat emulsion injection according to claim 1 or 5, is characterized in that: described fat emulsion injection be in/long chain fat emulsion injection, long chain fat emulsion injection (OO), in fish oil/long chain fat emulsion injection, fish oil fat emulsion injection or multiple oil and fat emulsion injection, middle long chain fat emulsion/aminoacid/glucose injection, long chain fat emulsion/aminoacid/glucose injection, long chain fat emulsion/aminoacid/glucose injection or multiple oil and fat breast/aminoacid/glucose injection in olive oil fat milk/aminoacid/glucose injection or fish oil.
7. prepare a method for fat emulsion injection, it is characterized in that, it comprises the steps:
1) oil phase and aqueous phase is prepared;
2) inject water to amount of preparation by after oil phase and aqueous phase mix and blend, cross high pressure homogenizer;
3) use high pressure homogenizer homogenizing again, obtain homogeneous latex emulsion;
4) fill, jump a queue after filling nitrogen, gland, sterilizing, obtain fat emulsion injection;
Wherein, in step 2) after homogenizing or add stabilizing agent after step 3) homogenizing; When step 1) prepares aqueous phase, in step 2) before homogenizing or after homogenizing, or pH adjusting agent is added after step 3) homogenizing.
8. the method preparing fat emulsion injection according to claim 7, is characterized in that: step 2) described in high pressure homogenizer be two step high pressure homogenizers, processing condition is: homogenization pressure is one-step valve 400 ~ 800bar, be preferably 600 ~ 800bar; Secondary valve is 0 ~ 200bar; Homogenization cycles is at 2 ~ 4 times, and homogenizing temperature is 50 ~ 65 DEG C.
9. the method preparing fat emulsion injection according to claim 7 or 8, it is characterized in that: the high pressure homogenizer described in step 3) is two step high pressure homogenizers, homogenization pressure is: homogenization pressure is one-step valve 120 ~ 200bar, secondary valve is 0 ~ 200bar, and homogenizing temperature is 50 ~ 65 DEG C.
10. the preparation method of fat emulsion injection according to claim 7, is characterized in that: the preparation method of oil phase described in step 1) is: get one or more in soybean oil, olive oil, medium chain triglyceride and fish oil, is heated to 60 ~ 85 DEG C and get final product; The preparation method of described aqueous phase is: get glycerol and add in appropriate water for injection, stirring and dissolving post-heating to 60 ~ 85 DEG C and get final product.
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